Manager, Training Program

The Manager of Training leads the site training program for a pharmaceutical manufacturing organization, ensuring employees and contractors are qualified to perform assigned work safely, consistently, and in compliance with current Good Manufacturing Practice (cGMP), company procedures, and applicable regulatory requirements. This role partners with Quality, Operations, Technical Services, Engineering, EHS, and Human Resources to build role-based curricula, maintain inspection-ready training records, strengthen trainer capability, and improve learning effectiveness. The position reports to the Head of Quality.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Own and continuously improve the site training system, including governance, procedures, curricula, qualification pathways, metrics, and periodic review.
• Ensure training assignments, completions, retraining, and qualification records are accurate, timely, traceable, and inspection ready.
• Develop and maintain role-based learning plans for GxP, technical, safety, quality-system, and compliance requirements.
• Partner with process owners and subject-matter experts to convert procedures, process changes, deviations, CAPAs, and regulatory commitments into effective training.
• Oversee the learning management system and associated data integrity, access, reporting, and change controls.
• Establish standards for instructor-led training, on-the-job training, train-the-trainer programs, knowledge checks, practical demonstrations, and qualification sign-off.
• Evaluate training effectiveness using assessments, observation, performance trends, deviation data, audit observations, and stakeholder feedback.
• Provide training metrics and risk-based insights to site leadership and governance forums; escalate overdue or ineffective training as appropriate. LMS administration which oversees eQMS for tracking training (e.g., MasterControl).
• Support internal audits, customer audits, and regulatory inspections by presenting the training system and retrieving supporting records.
• Lead, coach, and develop training specialists, coordinators, instructional designers, and qualified trainers, where applicable.
• Manage training vendors, materials, schedules, facilities, and budget within approved requirements.
• Promote a culture of continuous learning, quality ownership, and right-first-time execution.

QUALIFICATIONS

• Bachelor’s degree in life sciences, engineering, education, organizational development, business, or a related field; equivalent relevant experience may be considered.
• Five or more years of experience in pharmaceutical, biotechnology, medical device, or another regulated manufacturing environment, including at least two years in training, quality, operations, or a related leadership role.
• Working knowledge of cGMP principles, controlled documentation, data integrity, deviations, CAPA, change control, and inspection readiness.
• Experience administering a learning management system and producing reliable compliance reports.
• Demonstrated ability to design, deliver, and evaluate adult learning for technical and procedural content.
• Strong written, verbal, facilitation, project-management, and cross-functional influencing skills.

KNOWLEDGE, SKILLS, & ABILITIES

• Advanced degree or professional certification in instructional design, adult learning, quality, or organizational development.
• Deep familiarity with GMP, GDP, FDA 21 CFR regulations, EU regulations
• Experience supporting sterile, biologic, solid-dose, active pharmaceutical ingredients, packaging, laboratory, or warehouse operations.
• Experience with electronic document management, quality management, and learning platforms.
• Experience managing direct reports, external vendors, training budgets, or enterprise learning projects.
• Quality and compliance mindset
• Strategic planning and disciplined execution
• Clear communication and facilitation
• Coaching and talent development
• Sound judgment and risk-based decision-making
• Collaboration and stakeholder management
• Key Performance Indicator Management
• On-time completion of assigned training and retraining
• Timely qualification for new and transferred employees
• Training-record accuracy and audit readiness
• Effectiveness of curricula, trainers, and qualification methods
• Reduction in recurring errors or deviations linked to knowledge or skill gaps
• Timely completion of training actions arising from changes, CAPAs, and commitments

PHYSICAL REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Prolonged periods sitting at a desk and working on a computer.
• Must be able to lift up to 25 pounds at times.